Status:
ACTIVE_NOT_RECRUITING
Dutch Multidomain Lifestyle Intervention in Older Adults at Risk of Cognitive Decline
Lead Sponsor:
Alzheimercentrum Amsterdam
Collaborating Sponsors:
Maastricht University
Radboud University Medical Center
Conditions:
Cognitive Decline
Life Style
Eligibility:
All Genders
60-79 years
Phase:
NA
Brief Summary
FINGER-NL is a multi-center, randomized, controlled, multidomain lifestyle intervention trial among 1,206 older adults at risk for cognitive decline with a duration of 24 months. Participants are rand...
Eligibility Criteria
Inclusion
- 60-79 years of age at pre-screening;
- Adequate fluency in Dutch to understand the informed consent and complete questionnaires;
- Providing informed consent to all study procedures;
- Internet access at home;
- Presence of ≥3 self-reported risk factors for cognitive decline (must contain at least 2 modifiable risk factors and 1 non-modifiable riskfactor).
Exclusion
- Diagnosis of dementia or mild cognitive impairment at baseline (self-reported);
- Significant cognitive impairment assessed using the Modified Telephone Interview for Cognitive Status battery (TICSm score\<23);
- Conditions affecting safe and continuous engagement in the intervention (e.g. under treatment for current malignant diseases, major psychiatric disorders (e.g. major depression, psychosis, bipolar disorder), neurological disorders (e.g. Parkinson's disease, multiple sclerosis), symptomatic cardiovascular disease (e.g. stroke, angina pectoris, heart failure, myocardial infarction), re-vascularization within three months, severe loss of vision, hearing or communicative ability, severe mobility impairment, other conditions preventing co-operation) as judged by the local study nurse or consulted physician at the local study site;
- Coincident participation in any other intervention trial at time of pre-screening.
- Coincident participation of spouse in FINGER-NL trial.
Key Trial Info
Start Date :
February 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2027
Estimated Enrollment :
1210 Patients enrolled
Trial Details
Trial ID
NCT05256199
Start Date
February 24 2022
End Date
June 1 2027
Last Update
January 7 2025
Active Locations (5)
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1
Alzheimer Center Amsterdam
Amsterdam, Netherlands
2
University Medical Center Groningen
Groningen, Netherlands
3
Maastricht University
Maastricht, Netherlands
4
Radboud University
Nijmegen, Netherlands